Safety and Efficacy of the DALI LDL-adsorber and MONET Lipoprotein Filter

NCT ID: NCT01753232

Last Updated: 2015-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2015-08-31

Brief Summary

Low Density Lipoprotein (LDL)-apheresis refers to a procedure in which blood taken from a patient's vein is cleaned from pathogenic substances, e.g. cholesterol, outside the body and then given back to the patient. In the DALI (Direct Adsorption of Lipoproteins)-system whole blood is pumped over an adsorber containing beads that selectively bind LDL-cholesterol. The MONET (Membrane filtration Optimized Novel Extracorporeal Treatment)-system works with plasma which is cleaned by filtration. This study comprises the recording of safety and efficacy data from patients treated either with the DALI or MONET-system over a period of 2 years.

Detailed Description

Data were recorded from patients suffering from familial hypercholesterolemia and treated by lipid apheresis using one of the two systems investigated for at least 3 months prior to inclusion in the study. Only those treatments were documented in which routine blood samples for laboratory analysis were taken, or in which adverse or serious adverse device effects occur.

Conditions

Hypercholesterolemia, Familial; LIPOPROTEIN TYPES--Lp SYSTEM Lp(a) HYPERLIPOPROTEINEMIA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DALI-adsorber, hypercholesterolemia

Patients suffering from familial hypercholesterolemia treated at least twice a month with the DALI-system

DALI-adsorber

Intervention Type: DEVICE

Recording of treatment data. No extra interventional treatment

MONET-Filter, hypercholesterolemia

Patients suffering from familial hypercholesterolemia treated with the MONET-Lipoprotein filter

MONET-Lipoprotein filter

Intervention Type: DEVICE

Only treatment data recording. No extra interventional treatment

Interventions

DALI-adsorber

Recording of treatment data. No extra interventional treatment

Intervention Type: DEVICE

MONET-Lipoprotein filter

Only treatment data recording. No extra interventional treatment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• given informed consent
• 18 years or older
• patient compliant to therapy as prescribed
• at least two therapy sessions per month
• treatment with DALI or MONET system for at least 3 months before inclusion
• last severe invasive intervention in hospital more than 3 months ago

Exclusion Criteria

• earlier participation in the study
• unconscious patient/persons without capacity to contract
• for DALI: intake of ACE-inhibitors

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer Heinzler, MD

Role: PRINCIPAL_INVESTIGATOR

Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann

Franz Heigl, MD

Role: PRINCIPAL_INVESTIGATOR

Dres. Heigl, Hettich & Partner Medizinisches Versorgungszentrum

Frank Leistikow, MD

Role: PRINCIPAL_INVESTIGATOR

Nierenzentrum Mannheim

Frido Himmelsbach, MD

Role: PRINCIPAL_INVESTIGATOR

Apheresezentrum Ingelheim

Ralf Spitthöver, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum

Eberhard Roeseler, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Nieren,- Hochdruck und Stoffwechselerkrankungen Standort Heidering

Volker Schettler, MD

Role: PRINCIPAL_INVESTIGATOR

Nephrologisches Zentrum Goettingen

Gerd Schmitz, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Regensburg Department Clinical Chemistry and Laboratory Medicine

Nadim Abduhl-Rahman, MD

Role: PRINCIPAL_INVESTIGATOR

Dialysezentrum Magdeburg-Stadtfeld

Jens Ringel, MD

Role: PRINCIPAL_INVESTIGATOR

Dialysezentrum Potsdam

Wolfgang Ramlow, MD

Role: PRINCIPAL_INVESTIGATOR

Apheresezentrum Rostock

Locations

Nierenzentrum Mannheim

Mannheim, Baden Würtemberg, Germany

Medizinisches Versorgungszentrum

Kempten (Allgäu), Bavaria, Germany

Universitätsklinikum Regensburg Institut für Klinische Chemie und Laboratoriumsmedizin

Regensburg, Bavaria, Germany

Dialysezentrum Potsdam

Potsdam, Brandenburg, Germany

Nephrologisches Zentrum Goettingen

Göttingen, Lower Saxony, Germany

Zentrum für Nieren und Hochdruckkrankheiten Standort Heidering

Hanover, Lower Saxony, Germany

Apheresezentrum Rostock

Rostock, Mecklenburg-Vorpommern, Germany

Gemeinschaftspraxis Gysan, Heinzler, May, Hossmann

Cologne, North Rhine-Westphalia, Germany

Nephrologische Gemeinschaftspraxis Dialysezentrum/Lipidzentrum

Essen, North Rhine-Westphalia, Germany

Apheresezentrum Ingelheim

Ingelheim, Rhineland-Palatinate, Germany

Dialysezentrum Magdeburg-Stattfeld

Magdeburg, Saxony-Anhalt, Germany

Countries

Germany

Other Identifiers

TA-DALI-MONET-01-D

Identifier Type: -

Identifier Source: org_study_id